A Phase 1 interventional study of Low BPV Regimen in Blood Pressure Variability, sponsored by Cedars-Sinai Medical Center. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Cedars-Sinai Medical Center · Phase 1, Interventional, and Diagnostic
The purpose the research is to prospectively demonstrate agreement between EHR and ambulatory blood pressure monitor (ABPM) derived blood pressure variability (BPV), as well as the feasibility of reducing BPV using a data-driven pharmacotherapeutic approach. To this end, this is a feasibility study that will make use of the Cedars-Sinai Health System including the Medical Delivery Network and the clinics of all practitioners who use the same EHR.
The primary research procedures are: assessment of blood pressure variability (BPV) using ABPM compared to EHR derived values; and to assess feasibility of a data driven pharmacotherapy intervention to reduce BPV among high BPV patients. As part of an option sub-study, participants may wear a single lead ECG patch to record skin sympathetic nerve activity (SKNA), which has been previously correlated with changes in blood pressure.
Cedars-Sinai Medical Center is the lead sponsor of 455 studies on the registry; 108 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.
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Exclusion Criteria:
Participants on antihypertensive pharmacotherapy in the highest decile of BPV will be offered enrollment based on inclusion/exclusion criteria. Patient's will undergo a 48 hour ABPM to determine baseline BPV. Next, each patient's primary care physician will be guided through titrations to antihypertensive medications to a low BPV regimen (Amlodipine and Indapamide, with doses titrated to reach target blood pressure). Following this, patients will undergo repeat 48h ABPM to evaluate change in BPV. All medication decisions will be at the ultimate discretion of the treating physician. The optional sub-study will test the hypothesize that ABPM and SKNA data can be simultaneously captured and that BPV will be positively correlated with SKNA. Participants who enroll in the optional sub-study will be fitted with a single patch ECG which will capture high-fidelity ECG tracings from which SKNA can be determine in post-test analysis.
Drug: Low BPV Regimen
Each the patients' physician will invite patients to complete a 48-hour ABPM, then undergo cross-titration from their current antihypertensive regimen to a low BPV regimen, consisting of Amlodipine and Indapamide. Study staff will suggest to the treating physician to initially start patients on Amlodipine 5mg daily, with uptitration to 10mg daily to a goal systolic blood pressure (SBP)\<130 mmHg. Indapamide will be suggested to be added at 1.25mg daily and increased to 2.5mg daily, as needed to meet target SBP. Other antihypertensive medications will be suggested to be discontinued as the SBP target is reached. Patients not meeting target SBP on maximally tolerated Amlodipine and Indapamide will be suggested to have a long acting angiotensin-converting enzyme (ACE)/ angiotensin receptor blocker (ARB) added to their therapy. Patients will complete another 48-hour ABPM after 1 week at target SBP on the low-BPV regimen.
Change in Blood Pressure Variability
Change in Average Real Variability from pre-intervention 48h Ambulatory Blood Pressure Monitor (ABPM) and post-intervention 48 ABPM
Time frame: 48 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Dec 2026, 7 months later.
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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